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510(k) Data Aggregation

    K Number
    K213611
    Device Name
    Fenom Pro
    Manufacturer
    CAIRE Diagnostics Inc.
    Date Cleared
    2023-06-07

    (569 days)

    Product Code
    MXA
    Regulation Number
    862.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAIRE Diagnostics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fenom Pro is a portable, non-invasive device to measure fractional exhaled nitric oxide (FENO) in human breath. FENO is increased in some airway inflammatory processes, such as asthma, and decreases in response to anti-inflammatory treatment. Fenom Pro measures fractional exhaled nitric oxide according to guidelines established by the American Thoracic Society. Measurement of FENO by Fenom Pro is a non-invasive quantitative method to measure the decrease in FENO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy as an indication of therapeutic effect in patients with elevated FENO measurements are to be used as an adjunct to established clinical assessments. Fenom Pro is suitable for adults and children 6 years and older. Fenom Pro should be used in a point-of-care healthcare setting under professional supervision. Fenom Pro should not be used in critical care, emergency care or in anesthesiology.
    Device Description
    Fenom Pro is a non-invasive point-of-care breath analyzer for the quantitative measurement of fractional exhaled nitric oxide (FENO) in expired human breath. Fenom Pro is comprised of four major components. The main unit contains a touch screen interface for the user and houses the nitric oxide sensor and pneumatics needed to sample the patient's breath. The patient exhales into the Fenom Pro though a single use disposable mouthpiece which is attached to the handpiece. The handpiece is connected to the main unit via a breath tube. For testing, the patient inhales to total lung capacity and then slowly exhales into the mouthpiece for 6 or 10 seconds, depending on the mode of operation. Approximately 28 seconds after a successful breath maneuver, the FENO concentration is displayed in parts per billion (ppb) on the device touch screen. The device has a daily quality control procedure to ensure consistent device performance.
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